Documentation SkillPhase 2/3NCT01694888
Midwifery Students' Performance Before and After Teaching Fundamentals of Documentation
A Phase 2/3 study testing lecture in people with Documentation Skill, run by Mashhad University of Medical Sciences.
Trial summary
Midwives are responsible for documenting and keeping care facts in midwifery departments. Inaccurate documentation or even minute error in reporting may lead to burdensome responsibility for midwives. Read more about this study
- Who is it for?
- Ages 21 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Documentation Skill
- What is being tested?
- lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- midwifery students studying at mashhad school of nursing and midwifery
Who cannot join
- any other discipline
About this study
Midwives are responsible for documenting and keeping care facts in midwifery departments. Inaccurate documentation or even minute error in reporting may lead to burdensome responsibility for midwives. This study has been conducted aimed to compare midwifery students' performance before and after teaching fundamentals of documentation. In this quasi-experimental study, 28 midwifery students were participated. Data were collected by a questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary patient with physician order and a checklist contain 11 elements of documentation
- Conditions
- Documentation Skill
- Being tested
- lecture
- Keywords
- Students practice, Lecture; Nursing records; Nursing education; Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lectureOther
Teaching documentation skill using lecture method
| Study group | Role | What they receive |
|---|---|---|
| midwifery students | Experimental | all midwifery students studying at last term (except one who was absent) (27) in Mashhad school of nursing and midwifery in April 2011 Receives: Other: lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare midwifery students' performance before and after teaching fundamentals of documentation using lecture method
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Documentation SkillStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nazila zarghi, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694888
- Sponsor's protocol ID
- Documentation Skill
- Status last verified
- Apr 2011
- First submitted
- 17 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midwifery Students' Performance Before and After Teaching Fundamentals of Documentation
- ClinicalTrials.gov ID
- NCT01694888
- Acronym / sponsor ID
- Documentation Skill
- Conditions
- Documentation Skill
- Keywords
- Students practice, Lecture; Nursing records; Nursing education; Midwifery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Midwives are responsible for documenting and keeping care facts in midwifery departments. Inaccurate documentation or even minute error in reporting may lead to burdensome responsibility for midwives. This study has been conducted aimed to compare midwifery students' performance before and after teaching fundamentals of documentation. In this quasi-experimental study, 28 midwifery students were participated. Data were collected by a questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary patient with physician order and a checklist contain 11 elements of documentation
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| midwifery students | Experimental | Other: lectureall midwifery students studying at last term (except one who was absent) (27) in Mashhad school of nursing and midwifery in April 2011 |
Who may qualify
- Ages
- 21 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- midwifery students studying at mashhad school of nursing and midwifery
Key exclusion criteria (1 listed)
- any other discipline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lectureTeaching documentation skill using lecture method | Other | midwifery students |
Primary outcome
compare midwifery students' performance before and after teaching fundamentals of documentation using lecture method
Time frame: up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lecture in people with Documentation Skill, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare midwifery students' performance before and after teaching fundamentals of documentation using lecture method (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.